Registration Dossier

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was conducted prior to the validation of the LLNA method and the finalisation of the OECD testing guideline (429).

Test material

Constituent 1
Reference substance name:
1H-1,2,3-Benzotriazole
IUPAC Name:
1H-1,2,3-Benzotriazole
Constituent 2
Chemical structure
Reference substance name:
Benzotriazole
EC Number:
202-394-1
EC Name:
Benzotriazole
Cas Number:
95-14-7
Molecular formula:
C6H5N3
IUPAC Name:
1H-Benzotriazole
Test material form:
other: granules
Details on test material:
- Trade Name: Preventol CI-8
- Molecular formula (if other than submission substance): C6H5N3
- Molecular weight (if other than submission substance): 119.14 g/mol
- Smiles notation (if other than submission substance): c12c(cccc1)N=NN2
- InChl (if other than submission substance): 1S/C6H5N3/c1-2-4-6-5(3-1)7-9-8-6/h1-4H,(H,7,8,9)
- Structural formula attached as image file (if other than submission substance):

- Purity: 99.83 %
- Name of test material (as cited in study report): Benzotriazol Granulat (Preventol CI-8)
- Substance type: pale yellow granules
- Physical state: solid
- Analytical purity: 99.83 %
- Purity test date: 20.5.1986
- Lot/batch No.: 909
- Storage condition of test material: at 20.5 - 23 °C in the dark
- Other:

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: DHPW
Sex:
male
Details on test animals and environmental conditions:
animal number = 20
contol animal number = 10
TEST ANIMALS
- Source: Winkelmann, Borchen, Kreis Paderborn, Germany
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: 355 g mean (304 - 391 g)
- Housing: Makrolon cages type IV, 5 animals/cage
- Diet: Altromin3022 ad libitum
- Water: ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 2 °C
- Humidity (%): ca.50 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: intradermal and topical
Vehicle:
propylene glycol
Concentration / amount:
induction: 5 % and 25 %
challenge: 12 %
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
propylene glycol
Concentration / amount:
induction: 5 % and 25 %
challenge: 12 %
No. of animals per dose:
10
Details on study design:
first induction intradermal,
second induction topical one week later.
Challenge three weeks later.
Positive control substance(s):
yes
Remarks:
formaldehyde

Results and discussion

Positive control results:
weak positive response, 1/10 animals at the 24 hour observation

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
12 %
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 12 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
12 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 12 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
positive control
Dose level:
0.5 %
No. with + reactions:
15
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.5 %. No with. + reactions: 15.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
positive control
Dose level:
0.5 %
No. with + reactions:
8
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.5 %. No with. + reactions: 8.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
In this study there is no evidence that 1H-Benzotriazole is a skin sensitizer.
Executive summary:

For the source chemicals Benzotriazole and Tolyltriazole well-conducted tests according to OECD TG 406 are available showing no skin sensitizing potential. This means that a similar result for Sodium Benzotriazolate can be anticipated.

  Even though it is expected that Sodium Benzotriazolate will also not be sensitising to the skin, in any case the substance is classified as corrosive to the skin and anin vivoskin sensitisation study does not need to be conducted

Sodium Benzotriazolate is not skin sensitizing. A hazard characterization for the dermal route can be based on this information.

Classification and labeling are not needed for this endpoint.

A risk characterization will be performed because the substance is classified for oral toxicity.

Categories Display